FDA MedWatch – Certain Lots of NP Thyroid (Thyroid Tablets – USP) by Acella Pharmaceuticals:

TOPIC: Certain Lots of NP Thyroid (Thyroid Tablets – USP) by Acella Pharmaceuticals:  Recall: Due to Sub Potency

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy

ISSUE: Acella Pharmaceuticals is recalling certain lots of 15 mg, 30 mg, 60 mg, 90 mg and 120 mg NP Thyroid, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia.

To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall.

For the list of products and product pictures included this recall, click on the red button “Read Recall” below.

BACKGROUND: NP Thyroid, Thyroid Tablets – USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). 

RECOMMENDATIONS: 

• Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.